Impact of the COVID-19 Pandemic on the Surgical Activity of Bellvitge University Hospital

Sponsor

Hospital Universitari de Bellvitge (Other)

Overall Status

Completed

CT.gov ID

NCT04780594

Collaborator

(none)

2,530

Enrollment

Location

9.9

Actual Duration (Months)

256.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

COVID-19 has been a challenge for hospitals; there was an obvious need to reconvert many spaces in specific areas to attend this pathology, without forgetting the attention to other pathologies and surgery. The objective of the investigators is to evaluate the impact of this pandemic in the patients who underwent surgery in Bellvitge University Hospital, analyzing 2 periods of time: the months before the COVID-19 peak and the COVID-19 peak months.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Surgery--Complications Nosocomial Infection	Procedure: The study evaluates all surgical patients operated, both elective scheduled and emergent cases

Detailed Description

A total of 2.530 procedures have been evaluated in this retrospective observational study. Two groups have been generated (pre-pandemic period and pandemic period), classified into scheduled and emergency surgery. The investigators determined age, type of surgery and specialty, hospital stay, destination at discharge including mortality and severity according to Diagnostic Related to Group (DRG) scale. The investigators have also determined the number of confirmed COVID-19 infections in patients who underwent surgery during these 2 periods and evaluated if the infection was due to a nosocomial infection (confirmation of the COVID-19 during the hospitalization period). Comparisons were made between subgroups: scheduled surgery performed during the 2 periods and emergency surgery performed during the 2 periods.

Study Design

Study Type:

Observational

Actual Enrollment :

2530 participants

Observational Model:

Case-Crossover

Time Perspective:

Retrospective

Official Title:

Impact of the SARS-CoV-2 (COVID-19) Pandemic on the Morbidity and Mortality of Patients Undergoing Surgery at Bellvitge University Hospital

Actual Study Start Date :

Feb 13, 2020

Actual Primary Completion Date :

May 15, 2020

Actual Study Completion Date :

Dec 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Pre-pandemic COVID-19 group (PreCOVID) All patients who underwent surgery from 13th January until 29th February 2020, which are considered free of COVID-19 patients, therefore pre-pandemic period.	Procedure: The study evaluates all surgical patients operated, both elective scheduled and emergent cases Administrative database was automatically collected. That included demographic, clinical antecedents, surgical team and surgical procedure, primary and secondary diagnoses and principal and secondary surgical procedures. A case-mix grouping system administrative automatic recorded based on the ICD-10-AM International Classification of Diseases. According to the Diagnoses-related Groups (DRG's). the Severity of Illness Index assigns to each patient an overall severity score (from 1 to 4) and mortality risk score (from 1 to 4)
Pandemic COVID-19 group (COVID) All patients who underwent surgery from 11th March 2020 until 15th May 2020, which were done during the first wave of the pandemic crisis.	Procedure: The study evaluates all surgical patients operated, both elective scheduled and emergent cases Administrative database was automatically collected. That included demographic, clinical antecedents, surgical team and surgical procedure, primary and secondary diagnoses and principal and secondary surgical procedures. A case-mix grouping system administrative automatic recorded based on the ICD-10-AM International Classification of Diseases. According to the Diagnoses-related Groups (DRG's). the Severity of Illness Index assigns to each patient an overall severity score (from 1 to 4) and mortality risk score (from 1 to 4)

Arm

Intervention/Treatment

Pre-pandemic COVID-19 group (PreCOVID)

All patients who underwent surgery from 13th January until 29th February 2020, which are considered free of COVID-19 patients, therefore pre-pandemic period.

Procedure: The study evaluates all surgical patients operated, both elective scheduled and emergent cases

Administrative database was automatically collected. That included demographic, clinical antecedents, surgical team and surgical procedure, primary and secondary diagnoses and principal and secondary surgical procedures. A case-mix grouping system administrative automatic recorded based on the ICD-10-AM International Classification of Diseases. According to the Diagnoses-related Groups (DRG's). the Severity of Illness Index assigns to each patient an overall severity score (from 1 to 4) and mortality risk score (from 1 to 4)

Pandemic COVID-19 group (COVID)

All patients who underwent surgery from 11th March 2020 until 15th May 2020, which were done during the first wave of the pandemic crisis.

Procedure: The study evaluates all surgical patients operated, both elective scheduled and emergent cases

Outcome Measures

Primary Outcome Measures

Register the post-surgical complications [PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.]
Register and Compare the Rate of Surgical Reintervention between both periods.

Secondary Outcome Measures

Register the rate of surgical reintervention [PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.]
Register and compare the Rate of reintervention between both periods.
Register the ICU admission [PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.]
register and compare the ICU admission between both periods.
Register the Hospital stay [PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.]
register and compare the ICU admission between both periods.
Register the Mortality [PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.]
register and compare the Mortality between both periods.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

All surgical patients operated, both elective scheduled and emergent cases

Exclusion Criteria:

Minor-intermediate surgery that involves discharge from the hospital on the same day of the surgery from the Pre-pandemic period.
Procedures related to medical treatment or complications of COVID-19 patients, such as chest tubes, extracorporeal oxygenation or tracheostomy.
Those scheduled elective surgery patients in the Covid period that resulted RT-PCR positive, surgery was posponed, were not considered eligible for the analysis.